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Completed

NCT Number: NCT03035721

Clinical Evaluation of a Low Protein Content Formula in the First Months of Life: a RCT

This study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.

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Key information

Conditions

Safety Issues Infant Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

1 day–3 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NICU, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milan

Milan, 20122, Italy

About this study

Infants were randomized to receive either a standard protein formula or a low-protein formula. The composition of the low-protein formula vs the standard formula was: energy (65 vs. 68 kcal/100 mL), protein (1.2 vs. 1.7 g/100 mL).

To investigate the safety of the low-protein formula without any bias, a 4-month intervention period was selected during which the infants were fed only formula.

Anthropometric parameters (weight, length, and head circumference) and body composition were assessed at enrollment, at 2 and 4 months' of age. Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.

The reference group was constituted by a cohort of healthy, exclusively breastfed, full-term infants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy
  • singleton
  • full-term infants (gestational age 37/0 to 41/6 weeks)
  • birth weight adequate for gestational age (>p10 and <p90 for gestational age) according to the World Health Organization growth charts.

Exclusion criteria

  • presence of congenital diseases
  • presence of chromosomal abnormalities
  • presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections.
  • being born to mother affected by endocrine and/or metabolic diseases
  • having a family history of allergic disease

Treatment and study plan

Low protein formula

Dietary Supplement

Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.

Standard protein formula

Dietary Supplement

Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.

Primary outcomes

  1. Evaluate weight

    Time frame: enrollment, 2 months and 4 months

    Weight (g) of each baby was measured on an electronic scale accurate to 0.1 g (PEA POD Infant Body Composition System; Cosmed, Concord, CA, US). Body length was measured to the nearest 1 mm on a Harpenden neonatometer (Holtain, Crymych, UK).

  2. Evaluate lenght

    Time frame: enrollment 2 months and 4 months

    Lenght (cm) of each baby was measured according standard procedures.

  3. Evaluate head circumference

    Time frame: enrollment 2 months and 4 months

    Head circumference was measured to the nearest 1 mm using non-stretch measuring tape.

  4. Evaluate body composition (fat mass and fat free mass)

    Time frame: enrollment, 2 months and 4 months

    Body composition [fat mass and fat free mass (g)]was assessed using an air-displacement plethysmography (PEA POD Infant Body Composition System; COSMED, Italy).

  5. Evaluate weight increase

    Time frame: 2 months, 4 months

    Weight increase (g/day) was calculated as a change in body weight from weight at study enrollment divided by the time interval from enrolment to the assessment at 4 months Fat mass (g/day) and fat free mass (g/day) increases were also calculated.

  6. Evaluate gastrointestinal tolerance

    Time frame: 2 months and 4 months

    Parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls.

    The occurrence of spitting up, vomiting and colic, defined as intermittent attacks of abdominal pain when the baby screamed and drew up his/her legs but was well between episodes, was recorded. Colic was further classified as severe if the episodes were more than twice per day. Daily frequency of stool passage was also collected.

  7. Evaluate occurence of adverse events

    Time frame: 2 months and 4 months

    Adverse events were assessed based on inquires to the parents and on their daily records.

Secondary outcomes

  1. Evaluate body mass index (k/m2: weight/length2)

    Time frame: enrollment, 2 months and 4 months

    Body mass index [BMI: (Kg/m2)] was assessed for all infants enrolled at each study points.

  2. Evaluate z-score

    Time frame: enrollment, 2 months and 4 months

    Z-scores values for age were then calculated using the z score calculator provided by WHO [WHO Anthro (version 3.2.2, January 2011)].

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • Humana Co.Ltd.

Registry information

Official study title

Clinical Evaluation of a Low Protein Content Formula Fed to Full Term Healthy Infants in the First Months of Life: a Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 30, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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